Overview
Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Early Morning Blood Pressure and Central Arterial Pressure
Status:
Unknown status
Unknown status
Trial end date:
2015-09-01
2015-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran) with nifedipine controlled-release tablets (Adalat)in the treatment of Early Morning Blood Pressure and Central Arterial Pressure.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Shanghai Shyndec Pharmaceutical Co., Ltd.
Shanghai Shyndec Pharmaceutical Co.,Ltd.Treatments:
Nifedipine
Criteria
Inclusion Criteria:- Voluntarily participate and must sign informed consent form
- Mild to moderate essential hypertension (SBP 140-179 mmHg and/or DBP 90-109 mmHg)
- The mean morning blood press of one week >135/85 mmHg
Exclusion Criteria:
- Secondary hypertension and malignant hypertension
- Pregnant or nursing women, or patients that cannot guarantee to take effective
contraception measures
- Baseline SBP≥180 mmHg or DBP≥110 mmHg, or patients with cerebral, cardiac or renal
complications
- Have following complications: cerebrovascular accident within 6 months, myocardial
infarction or cardiac failure, macroaneurysm or dissecting aneurysm, definite angina,
A-V block of grade 2 or higher, sick sinus syndrome, atrial fibrillation or other
malignant arrhythmia
- Clinical significant diseases of heart, lung, liver, kidney and hematologic system or
malignant tumors, HIV infection, uncontrolled diabetes (fasting blood glucose ≥7.0
mmol/L, 2-hour postprandial blood glucose ≥7.8 mmol/L)
- Kock pouch
- Sever gastrointestinal stenosis
- Abnormal laboratory values with clinical significance, including serum potassium <3.5
or >5.5 mmol/L, glutamic-pyruvic transaminase (ALT) or glutamic oxalacetic
transaminase (AST) >2-fold upper limit of normal (ULN), Cr >ULN
- Gastrointestinal abnormalities or surgery that may interfere with drug absorption
- Hyperthyroidism or hypothyroidism
- Allergic to any ingredient or metabolite of investigational drug or drugs of similar
structure
- Psychological diseases, acrasia, cannot express explicitly
- Patients whose mood may be affected by variations in blood pressure, which in turn
increases blood pressure
- Anxiety disorders, depression or cannot follow study protocol
- BMI >30
- Night shift, irregular sleep patterns or insomnia
- participate in other clinical trials within 3 months
- other conditions that investigators consider unsuitable for participation